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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - plasma homocysteine lowering intervention - all type of patients

post stroke - prevention - patients with prior stroke or TIA


Related trials

CSPPT, 2015 - folic acid vs placebo

VITATOPS, 2010 - folic acid, vit B12 and vit B6 vs placebo

WAFACS, 2008 - folic acid, vit B12 and vit B6 vs placebo

WENBIT (vit B6), 2008 - vit B6 vs placebo

WENBIT (folic ac,B12), 2008 - folic acid, B12 vs placebo

SEARCH, 2007 - folic acid, B12 vs placebo

NORVIT (folic acid + B12) (Bonaa), 2006 - folic acid, B12 vs control

NORVIT (folic acid, B12 and vit B6) (Bonaa), 2006 - folic acid, vit B12 and vit B6 vs control

NORVIT (vit B6) (Bonaa), 2006 - vit B6 vs control

HOPE-2 (Lonn), 2006 - folic acid, vit B12 and vit B6 vs placebo

FOLARDA (Liem), 2004 - folic acid vs control

VISP (Toole), 2004 - high dose - folic acid, vit B12 and vit B6 vs low dose - folic acid, vit B12 and vit B6

GOES (Liem), 2003 - folic acid vs control

CHAOS-2, 2002 - folic acid vs placebo

SU.FOL.OM3, - folic acid, vit B12 and vit B6 vs placebo



See also:

  • All cardiovascular prevention clinical trials
  • All post stroke clinical trials
  • All clinical trials of prevention
  • All clinical trials of high dose - folic acid, vit B12 and vit B6
  •  
     VISP (Toole) study, 2004 TRC8857 
    download pdf: high dose - folic acid, vit B12 and vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment high-dose of folic acid, pyridoxine (vitamin B6), and cobalamin (vitamin B12)
    25 mg of pyridoxine, 0.4 mg of cobalamin, and 2.5 mg of folic acid
    Control treatment low-dose of folic acid, pyridoxine (vitamin B6), and cobalamin (vitamin B12)
    200 ìg of pyridoxine, 6 ìg of cobalamin, and 20 ìg of folic acid

    Patients

    Patients adults with nondisabling cerebral infarction
    Inclusion criteria Nondisabling ischemic stroke(Modified Rankin Stroke Scale <=3), onset <=120 days before; focal neurological deficit of likely atherothrombotic origin, classified as ischemic stroke by questionnaire/algorithm or confirmed as new cerebral infarction, consistent with symptoms by cranial computed tomography or brain magnetic resonance imaging; total homocysteine level >=25th percentile for North American stroke population; age >=35 years
    Baseline characteristics
    Age (yr) 66 y 
    Male sex 63% 
    BMI 28.1 
    diabetes (%) 29% 

    Method and design

    Randomized effectives 1827 / 1853 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 2 y
    Lost to follow-up 0.84% (31/)
    Number of centre 56
    Geographic area United States, Canada, Scotland
    Hypothesis Superiority
    Primary endpoint Recurrent cerebral infarction


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Any Ischemic stroke 152 / 1827 (8,3%) 148 / 1853 (8,0%) 1,04 [0,84;1,29]
    Fatal or disabling Ischemic stroke 21 / 1827 (1,1%) 18 / 1853 (1,0%) 1,18 [0,63;2,21]
    Any CHD 114 / 1827 (6,2%) 123 / 1853 (6,6%) 0,94 [0,73;1,20]
    MI or fatal CHD 72 / 1827 (3,9%) 81 / 1853 (4,4%) 0,90 [0,66;1,23]
    Any Ischemic stroke or CHD 249 / 1827 (13,6%) 257 / 1853 (13,9%) 0,98 [0,84;1,16]
    Fatal or disabling stroke or MI or fatal CHD 89 / 1827 (4,9%) 98 / 1853 (5,3%) 0,92 [0,70;1,22]
    Death 99 / 1827 (5,4%) 117 / 1853 (6,3%) 0,86 [0,66;1,11]
    Ischemic stroke, CHD, death 303 / 1827 (16,6%) 316 / 1853 (17,1%) 0,97 [0,84;1,12]
    Fatal or disabling stroke, MI, death 156 / 1827 (8,5%) 170 / 1853 (9,2%) 0,93 [0,76;1,15]

    Endpoints used by the meta-analysis and data retained for this trial

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    All cause death

    99 / 1827
    117 / 1853
    0,86 [0,66;1,11]

    stroke (fatal and non fatal)

    152 / 1827
    148 / 1853
    1,04 [0,84;1,29]

    Non fatal MI

    72 / 1827
    81 / 1853
    0,90 [0,66;1,23]

    cardiovascular events

    303 / 1827
    316 / 1853
    0,97 [0,84;1,12]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    All cause death 99 / 1827 (5,4%) 117 / 1853 (6,3%) 0,86 [0,66;1,11] Death  0
    Non fatal MI 72 / 1827 (3,9%) 81 / 1853 (4,4%) 0,90 [0,66;1,23] MI or fatal CHD  0
    cardiovascular events 303 / 1827 (16,6%) 316 / 1853 (17,1%) 0,97 [0,84;1,12] Ischemic stroke, CHD, death   0
    stroke (fatal and non fatal) 152 / 1827 (8,3%) 148 / 1853 (8,0%) 1,04 [0,84;1,29] Any Ischemic stroke   0
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 2 y)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 5,42% 6,31% -0,90%
    Non fatal MI 3,94% 4,37% -0,43%
    cardiovascular events 16,58% 17,05% -0,47%
    stroke (fatal and non fatal) 8,32% 7,99% 0,33%

    Meta-analysis of all similar trials:

    plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients

    prevention in post stroke for patients with prior stroke or TIA



    Reference(s)

    TrialResults-center ID TRC8857
    Trials register # NA
    • Spence JD, Bang H, Chambless LE, Stampfer MJ. Vitamin Intervention For Stroke Prevention trial: an efficacy analysis.. Stroke 2005 Nov;36:2404-9
      Pubmed | Hubmed | Fulltext
    • Toole JF, Malinow MR, Chambless LE, Spence JD, Pettigrew LC, Howard VJ, Sides EG, Wang CH, Stampfer M. Lowering homocysteine in patients with ischemic stroke to prevent recurrent stroke, myocardial infarction, and death: the Vitamin Intervention for Stroke Prevention (VISP) randomized controlled trial.. JAMA 2004 Feb 4;291:565-75
      Pubmed | Hubmed | Fulltext

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